Keep vein open infusion flow control device

ABSTRACT

Keep vein open (KVO) infusion flow control devices are provided. The KVO infusion flow control device couples to intravenous (IV) tubing and includes a flow controller that provides a full open fluid flow rate through an outlet portion of the IV tubing when the flow controller is in an open position, and a KVO fluid flow rate through the outlet portion of the IV tubing when the flow controller is in a KVO position. Visual indicators are disposed on the KVO infusion flow control device.

CROSS-REFERENCES TO RELATED APPLICATIONS

N/A

BACKGROUND

During use of an intravenous (IV) infusion set, occlusion in the IV lineis a common but undesirable occurrence to the patient's IV accessbecause of the clotting function of blood fibrin. The causes of catheterocclusion might be thrombotic, related to drug or parenteral nutritionprecipitates or mechanical. Occlusion due to this effect also providepotential nesting material for microorganisms and thus also increase therisk of catheter-related bloodstream infection. Typical solutions tocatheter occlusion are flushing and locking methods, such as tissueplasminogen activator (tPA), Heparin locks and catheter replacements.However, these typical flushing and locking methods have a significantimpact on clinician time and in-patient costs.

It is desirable to provide keep vein open (KVO), also known as to keepopen (TKO), infusion flow control devices having safe, consistent fluidflow control that can be easily set to keep fluid flow in the IV line ata KVO rate, thus reducing clinician time and in-patient costs.

SUMMARY

The present disclosure provides keep vein open infusion flow controldevices to rapidly and easily set gravity IV infusion rates to KVOwithout interaction with other IV infusion set components.

In one or more embodiments, a KVO infusion flow control device isprovided. The KVO infusion flow control device includes an inlet tubeconnector comprising an IV inlet port, a first outlet port and a secondoutlet port. The KVO infusion flow control device also includes anoutlet tube connector comprising an IV outlet port, a first inlet port,a second inlet port and a flow control orifice disposed within thesecond inlet port. The KVO infusion flow control device further includesa full flow tube coupled at one end to the first outlet port of theinlet tube connector and coupled at another end to the first inlet portof the outlet tube connector. The KVO infusion flow control device alsoincludes a KVO flow tube coupled at one end to the second outlet port ofthe inlet tube connector and coupled at another end to the second inletport of the outlet tube connector. The KVO infusion flow control devicefurther includes a flow controller coupled to the full flow tube.

In one or more aspects, the flow controller is configured to providefull fluid flow through the full flow tube into the outlet tubeconnector when the flow controller is disposed in a first position thatdoes not occlude the full flow tube. In one or more aspects, the flowcontroller is configured to shut off fluid flow through the full flowtube into the outlet tube connector when the flow controller is disposedin a second position that occludes the full flow tube to a predetermineddegree. In one or more aspects, the flow control orifice is configuredto limit fluid flow into the outlet tube connector when the flowcontroller is disposed in the second position. In one or more aspects,the flow control orifice is sized and shaped to provide a predeterminedKVO fluid flow rate into the outlet tube connector when the flowcontroller is disposed in the second position. In one or more aspects,an inlet connector is coupled to the IV inlet port, the inlet connectorconfigured to be coupled to an inlet IV tube.

In one or more aspects, an outlet connector is coupled to the IV outletport, the outlet connector configured to be coupled to an outlet IVtube. In one or more aspects, the inlet connector is a female Luerconnector and the outlet connector is a male Luer connector. In one ormore aspects, the flow control orifice comprises a tube engagementportion configured to couple with the KVO flow tube, the tube engagementportion having a narrower internal diameter than the internal diameterof the KVO flow tube. In one or more aspects, the flow control orificefurther comprises a restriction portion disposed adjacent to the tubeengagement portion, the restriction portion configured to block fluidflow from the tube engagement portion into the outlet connector. In oneor more aspects, the flow control orifice further comprises a flowportion disposed within the restriction portion, the flow portionconfigured to restrict fluid flow into the outlet connector to a KVOfluid flow rate. In one or more aspects, the flow controller is a pinchclamp.

In one or more embodiments, a KVO infusion flow control device isprovided. The KVO infusion flow control device includes a body, a fullopen member disposed on the body, a KVO member disposed on the bodyseparately from the full open member, a control member coupled to thebody and a visual indicator. A first position of the control member isconfigured to engage the full open member with a fluid flow path toprovide full fluid flow through an intravenous (IV) tube and a secondposition of the control member is configured to engage the KVO memberwith the fluid flow path to provide KVO fluid flow through the IV tube

In one or more aspects, the control member includes an open control armhaving a first visual indicator disposed thereon and a KVO control armhaving a second visual indicator disposed thereon, wherein the body isrotatably coupled to a fluid flow housing, the fluid flow housingincluding an inlet connector configured to receive a fluid inlet IV tubeat one portion of the fluid flow housing and an outlet connectorconfigured to receive a fluid outlet IV tube at another portion of thefluid flow housing, and wherein the full open member is a full openorifice in the body and the KVO member is a KVO orifice in the body.

In one or more aspects, a first flange is disposed circumferentiallyaround a portion of the inlet connector and a second flange is disposedcircumferentially around a portion of the outlet connector, wherein thefluid inlet IV tube is received in a gap between the first flange andthe inlet connector and the fluid outlet IV tube is received in a gapbetween the second flange and the outlet connector.

In one or more aspects, the control member includes a control switchhaving first and second visual indicators disposed thereon, wherein thebody is rotatably coupled to a fluid flow housing, the fluid flowhousing configured to receive a fluid inlet IV tube at one portion ofthe fluid flow housing and to receive a fluid outlet IV tube at anotherportion of the fluid flow housing, and wherein the full open member is afull open orifice in the body and the KVO member is a KVO orifice in thebody.

In one or more aspects, the control member includes a cam disposedwithin a tube channel in the body, the cam slidably engaged with one ormore cam channels in the body; and a ramp disposed at a base of the tubechannel, wherein the body has a boxlike shape with the visual indicatordisposed thereon, the body configured to receive the IV tube within thetube channel, wherein the full open member is a first portion of thebody having a low end of the ramp, the first portion of the bodyconfigured so that the IV tube is one of not engaged and not occludedwhen the cam is in the first position, and wherein the KVO member is asecond portion of the body having a high end of the ramp, the secondportion of the body configured to engage the IV tube such that the IVtube is occluded when the cam is engaged with the IV tube in the secondposition.

In one or more aspects, the control member includes a slide switchdisposed within a switch channel in the body, wherein the body is aboxlike housing with the visual indicator disposed thereon, the boxlikehousing configured to receive a fluid inlet IV tube at a first connectordisposed on a side wall of the body and to receive a fluid outlet IVtube at a second connector disposed on an opposing side wall of thebody, wherein the full open member is a full open channel disposedthrough a width of the slide switch, the full open channel configured toalign with the first and second connectors in the first position, andwherein the KVO member is a KVO channel disposed through the width ofthe slide switch, the KVO channel configured to align with the first andsecond connectors in the second position.

In one or more aspects, the control member includes a rocker switchpivotably disposed in a tube channel of the body, the rocker switchhaving the visual indicator disposed thereon and the body configured toreceive the IV tube in the tube channel, wherein the full open member isa first portion of the rocker switch having an open engagement membersized and shaped to engage the IV tube such that the IV tube is notoccluded when the rocker switch is in the first position, and whereinthe KVO member is a second portion of the rocker switch having a KVOengagement member sized and shaped to engage the IV tube such that theIV tube is occluded when the rocker switch is in the second position.

In one or more aspects, the control member includes a rocker switchpivotably disposed in a switch channel of the body, the body having atube channel configured to receive the IV tube, wherein the full openmember is an engagement surface of the rocker switch wherein the IV tubeis one of not engaged by the engagement surface and not occluded by theengagement surface when the rocker switch is in the first position, andwherein the KVO member comprises a retaining clip disposed on the bodyand an engagement member disposed on the rocker switch, the retainingclip configured to hold the engagement member so that the IV tube isoccluded by the engagement surface when the rocker switch is in thesecond position.

In one or more aspects, the control member includes a switch slidablycoupled to the body, the switch comprising: a leading portion disposedwithin the body; an exterior surface disposed within the body; a switchrib; and a switch connector configured to receive an inlet IV tube; thebody comprising: a body connector configured to receive an outlet IVtube; a valve disposed adjacent to the body connector, the valve havingpivotably connected valve flaps; a seal disposed on a portion of theexterior surface of the switch; and a gripper, wherein the full openmember comprises the gripper of the body retaining the switch rib andthe leading portion of the switch holding the valve flaps in an openposition when the switch is in the first position, and wherein the KVOmember comprises the leading portion of the switch removed fromengagement with the valve flaps and the valve flaps being biased in aclosed position having a KVO gap when the switch is in the secondposition.

Additional features and advantages of the disclosure will be set forthin the description below and, in part, will be apparent from thedescription or may be learned by practice of the disclosure. Theobjectives and other advantages of the disclosure will be realized andattained by the structure particularly pointed out in the writtendescription and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the disclosure as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the description serve to explain the principles of thedisclosure.

FIG. 1 is a perspective view of an example KVO infusion fluid flowcontrol device, according to some aspects of the disclosure.

FIG. 2 is a top view of the KVO infusion fluid flow control device ofFIG. 1 showing the fluid flow path with the pinch clamp open, accordingto some aspects of the disclosure.

FIG. 3 is a cross-sectional perspective view of the KVO infusion fluidflow control device of FIG. 2, according to some aspects of thedisclosure.

FIG. 4 is a top view of the KVO infusion fluid flow control device ofFIG. 1 showing the fluid flow path with the pinch clamp closed,according to some aspects of the disclosure.

FIG. 5 is a cross-sectional perspective view of the KVO infusion fluidflow control device of FIG. 4, according to some aspects of thedisclosure

FIG. 6 is an enlarged partial view of the KVO infusion fluid flowcontrol device of FIG. 5, according to some aspects of the disclosure.

FIG. 7 is a schematic view of the fluid volume throughout the KVOinfusion fluid flow control device of FIG. 1 for both all states,according to some aspects of the disclosure.

FIG. 8 is an enlarged partial view of the fluid volume of FIG. 7,according to some aspects of the disclosure.

FIG. 9 is a schematic view of a fluid flow velocity model of the KVOinfusion fluid flow control device of FIG. 2, according to some aspectsof the disclosure.

FIGS. 10A-10E are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 11A-11D are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 12A-12D are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 13A-13G are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 14A-14D are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 15A-15G are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 16A-16D are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

FIGS. 17A-17F are various views of a KVO infusion fluid flow controldevice, according to some aspects of the disclosure.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions are provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

Typical connectors and flow regulators for gravity IV infusion sets donot have a way of setting a specific KVO rate. While medical infusionpumps may have KVO rate setting features, KVO features are not typicallyfound on current gravity IV infusion sets.

According to some aspects of the disclosure, a KVO infusion flow controldevice allows a clinician (e.g., health care provider) to rapidly andeasily set gravity IV infusion rates to a KVO rate without interactionwith other components in the IV infusion set (e.g., catheter, flushsyringe, injection port, IV-line component, roller clamp, flowcontroller). This frees the clinician to perform other duties worry freeas the KVO infusion flow control device keeps the injection siteoperational while maintaining the KVO rate.

According to some aspects of the disclosure, the KVO infusion flowcontrol device reduces occlusion in the catheter and keeps the IV lineopen for future use. According to some aspects of the disclosure, theKVO infusion flow control device reduces the probabilities that bloodclots and drug precipitates will form, thus keeping the IV site (e.g.,injection site of needle in vein) operational over time. According tosome aspects of the disclosure, the KVO infusion flow control devicereduces connections necessary to maintain the IV site (e.g flushsyringe), thus keeping the IV site operational over time and reducingexposure to contaminants and infectious agents that could potentiallyenter the patient's bloodstream. According to some aspects of thedisclosure, the KVO infusion flow control device reduces blood refluxoccurrence due to a continual flow of IV fluid.

A KVO infusion flow control device 100 is shown in FIGS. 1-9, accordingto some aspects of the disclosure. The KVO infusion flow control device100 includes a full flow tube 110 and a KVO flow tube 120 that are eachcoupled to an inlet tube connector 130 (e.g., Y-connector) at one endand an outlet tube connector 140 (e.g., Y-connector) at the other end.The inlet tube connector 130 includes an IV inlet port 132, a firstoutlet port 134 and a second outlet port 136. The outlet tube connector140 includes an IV outlet port 142, a first inlet port 144 and a secondinlet port 146. The IV inlet port 132 is coupled to an inlet connector150 (e.g., female Luer connector) and the IV outlet port 142 is coupledto an outlet connector 160 (e.g., male Luer connector). A flowcontroller 170 (e.g., pinch clamp) is coupled to the full flow tube 110to provide control of the fluid flow through the full flow tube 110. Forexample, when the flow controller 170 is in an open position, the fluidmay have a fully open flow in the full flow tube 110, whereas when theflow controller 170 is in a closed position, fluid flow may becompletely blocked in the full flow tube 110. A flow control orifice 180(see FIGS. 2-6) is disposed within the second inlet port 146 and theflow control orifice 180 is sized and shaped to provide a desired KVOfluid flow rate.

As shown in FIGS. 2 and 3, with the flow controller 170 in an open flowsetting, the majority of the fluid flowing into the inlet tube connector130 takes the path of least resistance and flows out the first outletport 134 and through the full flow tube 110 along the open flow path X,according to some aspects of the disclosure. Here, some portion of fluidmay still flow out the second outlet port 136 and through the KVO flowtube 120, but the fluid flow is restricted by the flow control orifice180 such that the fluid backs up into the inlet tube connector 130. Thiscauses additional fluid coming into the inlet tube connector 130 from afluid source (e.g., fluid bag, needless syringe) to divert into the fullflow tube 110 and flow freely without restriction to the first inletport 144 and to exit the IV outlet port 142 at a fully open flow rate.

As shown in FIGS. 4 and 5, with the flow controller 170 in a flow offsetting, the majority of the fluid flowing into the inlet tube connector130 takes the path of least resistance and flows out the second outletport 136 and through the KVO flow tube 120 along the open flow path Y,according to some aspects of the disclosure. Here, a portion of fluidremains in the full flow tube 110 from the flow controller 170 to theinlet tube connector 130. This causes additional fluid coming into theinlet tube connector 130 from the fluid source (not shown) to divertinto the KVO flow tube 120 and flow freely through the KVO flow tube 120to the second inlet port 146 until being restricted by the flow controlorifice 180 in the outlet tube connector 140. The fluid then exits theIV outlet port 142 at a KVO flow rate.

As shown in FIG. 6, according to some aspects of the disclosure, theflow control orifice 180 may have a flow portion 182, a restrictionportion 184 and a tube engagement portion 186. The engagement portion isconfigured to engage or couple with the KVO flow tube 120. Theengagement portion 186 has a narrower internal diameter/volume than theKVO flow tube 120, which provides for a first restriction in the fluidflow into the outlet tube connector 140. The restriction portion 184 isconfigured to block the flow of fluid from the KVO flow tube 120 intothe outlet tube connector 140 through the area covered by therestriction portion 184. The flow portion 182 is a smaller opening(e.g., circular hole) disposed within the restriction portion 184 andconfigured to restrict fluid flow to a lower flow rate (e.g., KVO flowrate) than the fully open flow rate through the KVO flow tube 120 andthe first restricted flow rate through the engagement portion 186.

Thus, the size and shape of the flow portion 182 dictates the final flowrate of the fluid into the outlet tube connector 140. For example, aneonatal gravity IV set for use with an infant may have a KVO infusionflow control device 100 with a very small flow portion 182, thus causinga low KVO fluid flow rate that is appropriate for a small vein and/orbody size. As another example, a gravity IV set for large adults mayhave a KVO infusion flow control device 100 with a larger flow portion182, resulting in a higher KVO fluid flow rate that is appropriate for alarger vein and/or body size. The flow portion 182 may be configured asany shape (e.g., circle, square, oval, triangle), where different shapesmay provide different flow rates and fluid turbulence levels.

FIGS. 7 and 8 are schematic views depicting the available interiorvolume for fluid flow throughout the KVO infusion flow control device100. The smaller available fluid volume in the engagement portion 186provides for a somewhat restricted flow rate through the engagementportion 186. The much smaller available fluid volume in the flow portion182 provides for a more restricted flow rate (e.g., KVO flow rate)through the flow portion 182. Accordingly, the fluid flow output fromthe flow control orifice 180 into the outlet tube connector 140 iscontrolled at the KVO flow rate.

FIG. 9 is an internal view of a modeled static fluid flow profilethrough the KVO infusion flow control device 100 in the fully openposition. As shown, even when the vast majority of the fluid flowsthrough the full flow tube 110 when the flow controller 170 is in theopen position, a portion of the fluid still flows through the KVO flowtube 120 and through the flow control orifice 180. Thus, the fluid flowsfrom the full flow tube 110 and the flow control orifice 180 combinetogether in the outlet tube connector 140 and the combined fluid flowexits the outlet connector 160 at a full flow rate. By contrast, whenthe flow controller 170 is in the closed position, the fluid flowthrough the full flow tube 110 is cut off and the only fluid flow intothe outlet tube connector 140 comes from the flow control orifice 180,which then exits the outlet connector 160 at the KVO flow rate.

In operation, the KVO infusion flow control device 100 sets an IV set toopen when the KVO infusion flow control device 100 is in the openposition (e.g., not occluded), thus allowing for full fluid flow as seenin FIGS. 2, 3 and 9. When the KVO infusion flow control device 100 is inthe closed position (e.g., occluded), the KVO infusion flow controldevice 100 immediately sets the IV set to the KVO flow rate. Thus, theKVO infusion flow control device 100 may function as a binary fullflow/KVO flow rate switch that may be easily operated (e.g., one handedoperation) and is easily visualized as being in either the open flowposition or the KVO flow position (e.g., pinch clamp open or closed).Further, the KVO infusion flow control device 100 provides that nofurther interaction with other IV set components (e.g., roller clamp,flow controller) is necessary to regulate between full open flow and KVOflow. Thus, the simplified flow control operation of the KVO infusionflow control device 100 frees up time for a user (e.g., clinician,health care provider) to perform other care related tasks, whileproviding an intuitive and straightforward way to set the flow rate ofthe IV set with minimal operation or interaction.

In aspects of the disclosure, the KVO infusion flow control device 100provides for immediate feedback to the user when the flow controller 170is activated (e.g., closed), as well as allowing for single handedoperation by the user. The KVO infusion flow control device 100 alsoprovides simplified control over functionality of the IV set byproviding for quick and precise adjustment between open flow and KVOflow rates. The KVO infusion flow control device 100 may be attached aspart of an extension set stock keeping unit (SKU) and provides the userwith familiar IV set components (e.g., pinch clamp, Luer connectors).

In some aspects of the disclosure, a KVO infusion flow control device200 is configured as a stopcock device as shown in FIGS. 10A-10E. TheKVO infusion flow control device 200 includes a body 210 having a fullopen orifice 220 and a KVO orifice 230. An open control arm 240 and aKVO control arm 250 are coupled to the body 210. Visual indicators 260are disposed on the open control arm 240 and KVO control arm 250. Thebody 210 is coupled to a fluid flow housing 270 having connectors 272configured to receive IV tubes 280 for fluid inlet and fluid outlet.

In operation, the KVO infusion flow control device 200 may be controlledby grasping and turning the open control arm 240 and/or the KVO controlarm 250 to cause one of the full open orifice 220 and the KVO orifice230 to be in line with the fluid flow path, which causes the KVOinfusion flow control device 200 to operate between a full open flowrate and a KVO flow rate. In some aspects of the disclosure, the KVOinfusion flow control device 200 has no off setting for completelyshutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device300 is configured as a stopcock device as shown in FIGS. 11A-11D. TheKVO infusion flow control device 300 includes a body 310 having a fullopen orifice 320 and a KVO orifice 330. An open control arm 340 and aKVO control arm 350 are coupled to the body 310. Visual indicators 360are disposed on the open control arm 340 and KVO control arm 350. Thebody 310 is coupled to a fluid flow housing 370 having connectors 372configured to receive IV tubes 380 for fluid inlet and fluid outlet. Aflange 374 may be disposed around the connector 372 so that the tube 380is received between the connector 372 and the flange 374.

In operation, the KVO infusion flow control device 300 may be controlledby grasping and turning the open control arm 340 and/or the KVO controlarm 350 to cause one of the full open orifice 320 and the KVO orifice330 to be in line with the fluid flow path, which causes the KVOinfusion flow control device 300 to operate between a full open flowrate and a KVO flow rate. In some aspects of the disclosure, the KVOinfusion flow control device 300 has no off setting for completelyshutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device400 is configured as a stopcock device as shown in FIGS. 12A-12D. TheKVO infusion flow control device 400 includes a body 410 having a fullopen orifice 420 and a KVO orifice 430. A control switch 440 is coupledto the body 410, the control switch 440 configure to turn the body 410between an open position and a KVO position. Visual indicators 460 aredisposed on the control switch 440. The body 410 is coupled to a fluidflow housing 470 having connectors 472 configured to receive IV tubes480 for fluid inlet and fluid outlet.

In operation, the KVO infusion flow control device 400 may be controlledby grasping and turning the control switch 440 to cause one of the fullopen orifice 420 and a KVO orifice 430 to be in line with the fluid flowpath, which causes the KVO infusion flow control device 400 to operatebetween a full open flow rate and a KVO flow rate. In some aspects ofthe disclosure, the KVO infusion flow control device 400 has no offsetting for completely shutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device500 is configured as a roller clamp device as shown in FIGS. 13A-13G.The KVO infusion flow control device 500 includes a body 510 and a cam520 slidably disposed in cam channels 512 in the body 510. A ramp 514 isdisposed at a base of a tube channel 516 in the body 510, the tubechannel 516 configured to receive an IV tube 580. Visual indicators 560are disposed on the body 510.

In operation, the KVO infusion flow control device 500 may be controlledby pushing/pulling the cam 520 along the tube channel 516 of the body510 to cause the cam 520 to engage with and impinge IV tubing 580between the cam 520 and the ramp 514 of the body 510. Positioning thecam 520 in a fully open position causes the cam 520 to not occlude(e.g., deform, crush) the IV tubing 530 at all, which provides a fullopen fluid flow rate. Positioning the cam 520 in the KVO position causesthe cam 520 to occlude the IV tubing 530 enough to only allow a KVO flowrate. Thus, KVO infusion flow control device 500 operates between a fullopen flow rate and a KVO flow rate. In some aspects of the disclosure,the KVO infusion flow control device 500 has no off setting forcompletely shutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device600 is configured as a slide switch device as shown in FIGS. 14A-14D.The KVO infusion flow control device 600 includes a body 610 and aswitch 620 slidably disposed in a switch channel 612 in the body 610.The switch 620 includes a full open channel 630 and a KVO channel 640each disposed through the entire width of a switch housing 622.Connectors 670 are disposed on opposing sides of the body 610, theconnectors 670 configured to receive IV tubes 680. Visual indicators 660are disposed on the body 610.

In operation, the KVO infusion flow control device 600 may be controlledby pushing/pulling the switch 620 in the switch channel 612 of the body610 to align either the full open channel 630 or the KVO channel 640with the connectors 670. Positioning the switch 620 in a fully openposition causes the switch 620 to align the full open channel 630 withthe connectors 670 and correspondingly the IV tubes 680, which providesa full open fluid flow rate. Positioning the switch 620 in the KVOposition causes the switch 620 to align the KVO channel 640 with theconnectors 670 and correspondingly the IV tubes 680, which only allows aKVO flow rate. Thus, KVO infusion flow control device 600 operatesbetween a full open flow rate and a KVO flow rate. In some aspects ofthe disclosure, the KVO infusion flow control device 600 has no offsetting for completely shutting off the flow rate. In some aspects ofthe disclosure, the KVO infusion flow control device 600 may allow forcompletely shutting off the flow rate (e.g., the switch 620 ispositioned such that neither the full open channel 630 nor the KVOchannel 640 are aligned with the connectors 670).

In some aspects of the disclosure, a KVO infusion flow control device700 is configured as a rocker adapter device as shown in FIGS. 15A-15G.The KVO infusion flow control device 700 includes a body 710 and arocker switch 720 having a switch axle 722 pivotably disposed in a tubechannel 712 of the body 710. An open engagement member 730 is disposedat one end of the rocker switch 720 and is sized and shaped so as not toocclude (e.g., deform, crush) IV tubing 780 disposed in the tube channel712. A KVO engagement member 740 is disposed at the other end of therocker switch 720 and is sized and shaped to occlude IV tubing 780 to apredetermined degree when pressed into an activated position. Retainingclips 770 are disposed on both ends of the body 710 and are configuredto engage and retain whichever of the open engagement member 730 and theKVO engagement member 740 is activated (e.g., pressed into the tubechannel 712). Visual indicators 760 are disposed on the body 710.

In operation, the KVO infusion flow control device 700 may be controlledby pushing one end of the rocker switch 720 to cause the correspondingopen engagement member 730 or KVO engagement member 740 to press downinto the tube channel 712 in which the IV tubing 780 is disposed.Pushing the rocker switch 720 on the open end causes the open engagementmember 730 to either not engage with the IV tubing 780 at all or toengage with but not occlude the IV tubing 780, which provides a fullopen fluid flow rate. Here, the open engagement member 730 is capturedand retained by the retaining clips 770 disposed on the open end.Pushing the rocker switch 720 on the KVO end causes the KVO engagementmember 740 to engage with and occlude the IV tubing 780 enough to onlyallow a KVO flow rate. Here, the KVO engagement member 740 is capturedand retained by the retaining clips 770 disposed on the KVO end. Thus,KVO infusion flow control device 700 operates between a full open flowrate and a KVO flow rate. In some aspects of the disclosure, the KVOinfusion flow control device 700 has no off setting for completelyshutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device800 is configured as a rocker adapter device as shown in FIGS. 16A-16D.The KVO infusion flow control device 800 includes a body 810 and arocker switch 820 having a switch axle 822 pivotably disposed in aswitch channel 812 of the body 810. A tube channel 814 is disposed inthe body 810 and is configured to receive an IV tube 880. A clipengagement member 830 is disposed on the rocker switch 820 and is sizedand shaped to engage with and be retained by a retaining clip 870disposed on the body 810. An engagement surface 840 is disposed on therocker switch 820 and is configured to engage with and occlude the IVtubing 880 to a predetermined degree when the rocker switch 820 ispressed into an activated position. Visual indicators (not shown) may bedisposed on the body 810.

In operation, the KVO infusion flow control device 800 may be controlledby pushing/pulling the rocker switch 820 into an open position to movethe engagement surface 840 away from the tube channel 814 in which theIV tubing 880 is disposed, causing the engagement surface 840 to eithernot engage with the IV tubing 880 at all or to engage with but notocclude the IV tubing 880, which provides a full open fluid flow ratethrough the IV tubing 880. The KVO infusion flow control device 800 mayalso be controlled by pushing/pulling the rocker switch 820 into a KVOposition to move the engagement surface 840 toward the tube channel 814in which the IV tubing 880 is disposed, causing the engagement surface840 to engage with and occlude the IV tubing 880 a determined amount,thus only allowing a KVO fluid flow rate through the IV tubing 880.Here, the clip engagement member 830 is captured and retained by theretaining clip 870 to hold it in the KVO (e.g., activated) position.Thus, KVO infusion flow control device 800 operates between a full openflow rate and a KVO flow rate. In some aspects of the disclosure, theKVO infusion flow control device 800 has no off setting for completelyshutting off the flow rate.

In some aspects of the disclosure, a KVO infusion flow control device900 is configured as an inline switch device as shown in FIGS. 17A-17F.The KVO infusion flow control device 900 includes a body 910 and aswitch 920 slidably engaged with the body 910. The body 910 includes abody connector 930 and the switch 920 includes a switch connector 940,each sized and shaped to receive IV tubes 980. The body 910 alsoincludes a valve 950 disposed adjacent to the body connector 930 withinthe body 910. The valve 950 includes valve flaps 952 that are configuredto be biased towards a closed position (e.g., valve flaps 952 alignedorthogonally to an axial fluid flow channel within the body 910), whichprovides a KVO gap 954 between the valve flaps. The valve flaps 952 maybe pivotably connected to the valve 950 (e.g., like hinged swingingdoors) such that they can be pivoted open (e.g., swing open) when aleading portion 922 of the switch 920 engages and exerts a force on thevalve flaps 952. The body 910 also includes a seal 960 configured toengage an exterior surface 924 of the switch 920 throughout the fullrange of slidable motion within the body 910, thus providing a sealingbarrier preventing leakage of liquid from the KVO infusion flow controldevice 900. Visual indicators (not shown) may be disposed on the body910 and/or the switch 920. The switch 920 includes switch ribs 926 andthe body 910 includes body ribs 916, where the switch ribs 926 and thebody ribs 916 provide for ergonomic gripping of the switch 920 and thebody 910. The body 910 also includes grippers 970 disposed on an endadjacent to the switch 920, the grippers 970 configured to engage andretain a switch rib 926, thus locking a flow rate of the KVO infusionflow control device 900.

In operation, the KVO infusion flow control device 900 may be controlledby pushing/pulling the switch 920 towards/away from the valve 950. Herethe leading portion 922 of the switch 920 remains within the body 910when the switch 920 is in each of an open position and a KVO position.Pushing the switch 920 to the open setting causes the leading portion922 to engage with the valve flaps 952 and force the valve flaps 952 topivot inwards towards the body connector 930, thus opening a full flowpath to allow an open fluid flow rate out the body connector 930 into anoutlet IV tube 980. Pulling the switch 920 out to the KVO setting causesthe leading portion 922 to disengage with the valve flaps 952 and allowthe biasing force of the valve flaps 952 to pivot the valve flaps 952away from the body connector 930 and to align orthogonally to an axialfluid flow channel within the body 910, thus providing the KVO gap 954to allow only a KVO fluid flow rate out the body connector 930 into anoutlet IV tube 980. Thus, KVO infusion flow control device 900 operatesbetween a full open flow rate and a KVO flow rate. In some aspects ofthe disclosure, the KVO infusion flow control device 900 has no offsetting for completely shutting off the flow rate.

It is understood that any specific order or hierarchy of blocks in themethods of processes disclosed is an illustration of example approaches.Based upon design or implementation preferences, it is understood thatthe specific order or hierarchy of blocks in the processes may berearranged, or that all illustrated blocks be performed. In someimplementations, any of the blocks may be performed simultaneously.

The present disclosure is provided to enable any person skilled in theart to practice the various aspects described herein. The disclosureprovides various examples of the subject technology, and the subjecttechnology is not limited to these examples. Various modifications tothese aspects will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps,operations or processes disclosed is an illustration of exemplaryapproaches. Based upon design preferences, it is understood that thespecific order or hierarchy of steps, operations or processes may berearranged. Some of the steps, operations or processes may be performedsimultaneously. Some or all of the steps, operations, or processes maybe performed automatically, without the intervention of a user. Theaccompanying method claims, if any, present elements of the varioussteps, operations or processes in a sample order, and are not meant tobe limited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod claim, the element is recited using the phrase “step for.”Furthermore, to the extent that the term “include,” “have,” or the likeis used, such term is intended to be inclusive in a manner similar tothe term “comprise” as “comprise” is interpreted when employed as atransitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should theybe interpreted in such a way.

The invention claimed is:
 1. A keep vein open (KVO) infusion flowcontrol device, comprising: an inlet tube connector comprising anintravenous (IV) inlet port, a first outlet port and a second outletport; an outlet tube connector comprising an IV outlet port, a firstinlet port, a second inlet port and a flow control orifice disposedwithin the second inlet port; a full flow tube coupled at one end to thefirst outlet port of the inlet tube connector and coupled at another endto the first inlet port of the outlet tube connector; a KVO flow tubecoupled at one end to the second outlet port of the inlet tube connectorand coupled at another end to the second inlet port of the outlet tubeconnector; and a flow controller coupled to the full flow tube, whereinthe flow control orifice comprises a tube engagement portion disposedwithin the KVO flow tube, the tube engagement portion having a narrowerinternal diameter than an internal diameter of the KVO flow tube, thetube engagement portion configured to provide a first restricted fluidflow rate from the KVO flow tube to the outlet tube connector.
 2. TheKVO infusion flow control device of claim 1, wherein the flow controlleris configured to provide full fluid flow through the full flow tube intothe outlet tube connector when the flow controller is disposed in afirst position that does not occlude the full flow tube.
 3. The KVOinfusion flow control device of claim 1, wherein the flow controller isconfigured to shut off fluid flow through the full flow tube into theoutlet tube connector when the flow controller is disposed in a secondposition that occludes the full flow tube to a predetermined degree. 4.The KVO infusion flow control device of claim 3, wherein the flowcontrol orifice is configured to limit fluid flow into the outlet tubeconnector when the flow controller is disposed in the second position.5. The KVO infusion flow control device of claim 4, wherein the flowcontrol orifice is sized and shaped to provide a predetermined KVO fluidflow rate into the outlet tube connector when the flow controller isdisposed in the second position.
 6. The KVO infusion flow control deviceof claim 1, further comprising an inlet connector coupled to the IVinlet port, the inlet connector configured to be coupled to an inlet IVtube.
 7. The KVO infusion flow control device of claim 6, furthercomprising an outlet connector coupled to the IV outlet port, the outletconnector configured to be coupled to an outlet IV tube.
 8. The KVOinfusion flow control device of claim 7, wherein the inlet connector isa female Luer connector and the outlet connector is a male Luerconnector.
 9. The KVO infusion flow control device of claim 1, whereinthe flow control orifice further comprises a restriction portiondisposed within the outlet tube connector and adjacent to the tubeengagement portion, the restriction portion configured to block fluidflow from the tube engagement portion into the outlet tube connector.10. The KVO infusion flow control device of claim 9, wherein the flowcontrol orifice further comprises a flow portion disposed within therestriction portion, the flow portion configured to provide a secondrestricted fluid flow rate through the outlet tube connector, whereinthe second restricted fluid flow rate is a KVO fluid flow rate that isless than the first restricted fluid flow rate.
 11. The KVO infusionflow control device of claim 1, wherein the flow controller is a pinchclamp.
 12. A keep vein open (KVO) infusion flow control device,comprising: a body; a full open member disposed on the body; a KVOmember disposed on the body separately from the full open member; acontrol member coupled to the body, the control member comprising: a camdisposed within a tube channel in the body, the cam slidably engagedwith one or more cam channels in the body; and a ramp disposed at a baseof the tube channel; and a visual indicator, wherein a first position ofthe control member is configured to engage the full open member with afluid flow path to provide full fluid flow through an intravenous (IV)tube and a second position of the control member is configured to engagethe KVO member with the fluid flow path to provide KVO fluid flowthrough the IV tube, wherein the body has a rectangular shape with thevisual indicator disposed thereon, the body configured to receive the IVtube within the tube channel, wherein the full open member is a firstportion of the body having a low end of the ramp, the first portion ofthe body configured so that the IV tube is not occluded when the cam isin the first position, and wherein the KVO member is a second portion ofthe body having a high end of the ramp, the second portion of the bodyconfigured to engage the IV tube such that the IV tube is partiallyoccluded to provide the KVO fluid flow when the cam is engaged with theIV tube in the second position.
 13. A keep vein open (KVO) infusion flowcontrol device, comprising: a body; a full open member disposed on thebody; a KVO member disposed on the body separately from the full openmember; a control member coupled to the body; and a visual indicator,wherein a first position of the control member is configured to engagethe full open member with a fluid flow path to provide full fluid flowthrough an intravenous (IV) tube and a second position of the controlmember is configured to engage the KVO member with the fluid flow pathto provide KVO fluid flow through the IV tube, wherein the controlmember comprises a slide switch disposed within a switch channel in thebody, wherein the body is a rectangular shaped housing with the visualindicator disposed thereon, the rectangular shaped housing configured toreceive a fluid inlet IV tube at a first connector disposed on a sidewall of the body and to receive a fluid outlet IV tube at a secondconnector disposed on an opposing side wall of the body, wherein thefull open member is a full open channel disposed through a width of theslide switch, the full open channel configured to align with the firstand second connectors in the first position, and wherein the KVO memberis a KVO channel disposed through the width of the slide switch, the KVOchannel configured to align with the first and second connectors in thesecond position.
 14. A keep vein open (KVO) infusion flow controldevice, comprising: a body; a full open member disposed on the body; aKVO member disposed on the body separately from the full open member; acontrol member coupled to the body; and a visual indicator, wherein afirst position of the control member is configured to engage the fullopen member with a fluid flow path to provide full fluid flow through anintravenous (IV) tube and a second position of the control member isconfigured to engage the KVO member with the fluid flow path to provideKVO fluid flow through the IV tube, wherein the control member comprisesa rocker switch pivotably disposed in a tube channel of the body, therocker switch having the visual indicator disposed thereon and the bodyconfigured to receive the IV tube in the tube channel, wherein the fullopen member is a first portion of the rocker switch having an openengagement member sized and shaped to engage the IV tube such that theIV tube is not occluded when the rocker switch is in the first position,and wherein the KVO member is a second portion of the rocker switchhaving a KVO engagement member sized and shaped to engage the IV tubesuch that the IV tube is occluded when the rocker switch is in thesecond position.
 15. A keep vein open (KVO) infusion flow controldevice, comprising: a body; a full open member disposed on the body; aKVO member disposed on the body separately from the full open member; acontrol member coupled to the body; and a visual indicator, wherein afirst position of the control member is configured to engage the fullopen member with a fluid flow path to provide full fluid flow through anintravenous (IV) tube and a second position of the control member isconfigured to engage the KVO member with the fluid flow path to provideKVO fluid flow through the IV tube, wherein the control member comprisesa rocker switch pivotably disposed in a switch channel of the body, thebody having a tube channel configured to receive the IV tube, whereinthe full open member is an engagement surface of the rocker switchwherein the IV tube is one of not engaged by the engagement surface andnot occluded by the engagement surface when the rocker switch is in thefirst position, and wherein the KVO member comprises a retaining clipdisposed on the body and an engagement member disposed on the rockerswitch, the retaining clip configured to hold the engagement member sothat the IV tube is occluded by the engagement surface when the rockerswitch is in the second position.
 16. A keep vein open (KVO) infusionflow control device, comprising: a body; a full open member disposed onthe body; a KVO member disposed on the body separately from the fullopen member; a control member coupled to the body; and a visualindicator, wherein a first position of the control member is configuredto engage the full open member with a fluid flow path to provide fullfluid flow through an intravenous (IV) tube and a second position of thecontrol member is configured to engage the KVO member with the fluidflow path to provide KVO fluid flow through the IV tube, wherein thecontrol member comprises: a switch slidably coupled to the body, theswitch comprising: a leading portion disposed within the body; anexterior surface disposed within the body; a switch rib; and a switchconnector configured to receive an inlet IV tube; wherein the bodycomprises: a body connector configured to receive an outlet IV tube; avalve disposed adjacent to the body connector, the valve havingpivotably connected valve flaps; a seal disposed on a portion of theexterior surface of the switch; and a gripper, wherein the full openmember comprises the gripper of the body retaining the switch rib andthe leading portion of the switch holding the valve flaps in an openposition when the switch is in the first position, and wherein the KVOmember comprises the leading portion of the switch removed fromengagement with the valve flaps and the valve flaps being biased in aclosed position having a gap when the switch is in the second position.